KR20220131320A - Blood collection adapters and related devices to reduce hemolysis - Google Patents

Abstract

The adapter may include a distal end that may be configured to couple to a catheter assembly. The adapter may include a proximal end, which may include a proximal connector configured to couple to a blood collection device. The adapter may include a fluid path disposed between the distal end and the proximal end, the fluid path comprising a non-linear portion. The non-linear portion may form a coil shape, an S-shape, or other suitable shape.

Description

Blood collection adapters and related devices to reduce hemolysis

Typically, catheters are used for a variety of infusion regimens. For example, catheters can be used to inject fluids into a patient, such as physiological saline, various drugs, and total parenteral nutrition. The catheter may also be used to draw blood from a patient.

A common type of catheter is a peripheral venous (“IV”) catheter over a needle. As its name implies, an over-the-needle can be mounted over an introducer needle with a sharp distal tip. The catheter assembly may include a catheter hub, a catheter extending distally from the catheter hub, and an introducer needle extending through the catheter. The catheter and introducer needle may be assembled such that the distal tip of the introducer needle extends beyond the distal end of the catheter with the bevel of the opposing needle away from the patient's skin. Catheters and introducer needles are generally inserted through the skin at a shallow angle into the patient's vasculature.

To confirm proper placement of the introducer needle and/or catheter in the blood vessel, the clinician typically checks to see if there is a "flashback" of blood in the flashback chamber of the catheter assembly. Once the location of the needle is confirmed, the clinician can temporarily block the flow of the vasculature and remove the needle, leaving the catheter in place for future blood retrieval or fluid infusion.

A blood collection vessel may be used to withdraw blood or to take a blood sample from a patient. The blood collection container may include a syringe. Alternatively, the blood collection container may include a test tube with a rubber stopper at one end. In some cases, the test tube is purged of all or part of the air from the tube, such that the pressure in the tube is lower than the ambient pressure. Such blood collection vessels are often referred to as internal vacuum or vacuum tubes. A commonly used blood collection vessel is the VACUTAINER ^® blood collection tube available from Becton Dickinson & Company.

The blood collection vessel may be coupled to the catheter. When the blood collection container is coupled to the catheter, the pressure in the vein is higher than the pressure in the blood collection container, which pushes the blood into the blood collection container and fills the blood collection container. The vacuum in the blood collection container decreases as the blood collection container fills until the pressure in the blood collection container equals the pressure in the vein and blood flow stops.

Unfortunately, as blood flows into the blood collection vessel, the red blood cells are in a state of high shear stress and are prone to hemolysis due to the high initial pressure difference between the vein and the blood collection vessel. Hemolysis can result in rejection and disposal of blood samples. A high initial pressure differential can also lead to catheter tip damage, vein damage, or other complications that prevent or limit the filling of the blood collection vessel with blood. When the blood collection vessel is filled, the pressure difference between the vein and the blood collection vessel decreases and the rate at which the blood collection vessel is filled with blood is greatly slowed down.

The subject matter of the present invention is not limited to embodiments that solve any drawbacks or operate only in environments such as those described above. Rather, this background is provided to illustrate one exemplary area of technology in which some implementations described herein may be practiced.

The present invention relates generally to adapters configured to reduce the likelihood of hemolysis using a vascular access device, as well as related blood collection sets, systems and methods.

In some embodiments, the adapter may include a distal end that may be configured to couple to a catheter assembly. In some embodiments, the adapter may include a proximal end that may include a proximal connector configured to couple to a blood collection device. In some embodiments, the adapter may include a fluid path disposed between the distal end and the proximal end, wherein the fluid path comprises a non-linear portion.

In some embodiments, the non-linear portion may form a coil shape, an S-shape, or other suitable shape. In some embodiments, the non-linear portion may extend through the tube. In some embodiments, the adapter may include a lumen and the lumen may extend through a distal end of the adapter and a proximal end of the adapter. In some embodiments, the tube may be disposed within a lumen. In some embodiments, the adapter may include an intermediate portion disposed between a distal end and a proximal end. In some embodiments, the intermediate portion may surround the tube.

In some embodiments, the distal connector may comprise a male luer threaded connector, a male luer slip connector, a blunt cannula, or other suitable connector. In some embodiments, the proximal connector may include a female luer connector. In some embodiments, the proximal end may be coupled to a blood collection device. For example, the proximal end may be integrated with the blood collection device or formed integrally with the blood collection device as a single unit. As another example, the proximal end may include a female luer connector capable of mating with a male luer connector of a blood collection device.

In some embodiments, the blood collection device may include a syringe. In some embodiments, the blood collection device may include a needle configured to puncture the seal of the vacuum blood collection tube. In these and other embodiments, the blood collection device may include a cylindrical holder that may extend around the needle and may be configured to receive a vacuum blood collection tube.

It is to be understood that both the foregoing general description and the following detailed description are illustrative and descriptive representations and not restrictive. It should be understood that the various embodiments are not limited to the arrangements and instrumentalities shown in the drawings. Further, it is to be understood that embodiments may be combined, other embodiments may be utilized, and structural changes may be made without departing from the scope of various embodiments of the present invention unless structural changes are claimed. Accordingly, the following detailed description should not be taken in a limiting sense.

Exemplary embodiments will be described and explained in further detail and detail through the use of the accompanying drawings as follows:
1A is a top perspective view of an exemplary adapter in accordance with some embodiments.
1B is a cross-sectional view of the adapter of FIG. 1A in accordance with some embodiments.
2A is a top perspective view of the adapter of FIG. 1A integrated with an exemplary blood collection device in accordance with some embodiments.
2B is a cross-sectional view of the adapter of FIG. 1A integrated with the blood collection device of FIG. 2A in accordance with some embodiments.
2C is a top perspective view of the adapter of FIG. 1A integrated with another exemplary blood collection device in accordance with some embodiments.
2D is a top perspective view of the adapter of FIG. 1A integrated with another exemplary blood collection device in accordance with some embodiments.
3A is a top perspective view of another exemplary adapter in accordance with some embodiments.
3B is a cross-sectional view of the adapter of FIG. 3A in accordance with some embodiments.
4A is a top perspective view of another exemplary adapter in accordance with some embodiments.
4B is a cross-sectional view of the adapter of FIG. 4A in accordance with some embodiments.
5 is a cross-sectional view of another exemplary adapter in accordance with some embodiments.
6A is an exploded view of another exemplary adapter in accordance with some embodiments.
6B is a cross-sectional view of an exemplary outer component in accordance with some embodiments.
6C is a cross-sectional view of the adapter of FIG. 6A in accordance with some embodiments.

Referring now to FIGS. 1A-1B , an adapter 10 is shown in accordance with some embodiments. In some embodiments, adapter 10 may be configured to reduce the likelihood of hemolysis during blood draw using a vascular access device. In some embodiments, the vascular access device may include a catheter assembly. In some embodiments, the adapter 10 may include a distal end 12 , which may include a distal connector 14 configured to couple to a catheter assembly. In some embodiments, the distal connector 14 may comprise a male luer threaded connector as shown in FIGS. 1A-1B or other suitable connector.

In some embodiments, the catheter assembly may include a catheter hub, which may include a distal end, a proximal end, and a lumen extending through the distal and proximal ends. In some embodiments, the catheter assembly may include a catheter, which may be secured within a catheter hub and may extend away from a distal end of the catheter hub. In some embodiments, the catheter may comprise a peripheral venous catheter (PIVC), a peripherally inserted central catheter (PICC), or a midline catheter.

In some embodiments, the catheter assembly may comprise or correspond to any suitable catheter assembly. In some embodiments, the catheter assembly may be integrated and may include an extension tube that may extend from and be integrated with a side port of the catheter hub. A non-limiting example of an integrated catheter assembly is the BD NEXIVA™ Closed IV Catheter system available from Becton Dickinson and Company of Franklin Lakes, New Jersey. In some embodiments, the proximal end of the extension tube may be coupled to another adapter, such as a Y-adapter, for example. In some embodiments, adapter 10 may be configured to connect to another adapter.

In some embodiments, the catheter assembly may not be integrated and may not include an extension tube. In these and other embodiments, adapter 10 may be configured to couple to a proximal end of a catheter hub or other suitable portion of a catheter assembly. In some embodiments, the adapter 10 may be coupled directly to the catheter adapter to eliminate the extension tube and provide a compact catheter system.

In some embodiments, adapter 10 may include a proximal end 16 , which may include a proximal connector 18 configured to couple to a blood collection device. In some embodiments, the proximal connector 18 may include a female luer connector or other suitable connector. In some embodiments, the adapter 10 may include a fluid path 20 disposed between the distal end 12 and the proximal end 16 . In some embodiments, fluid in fluid pathway 20 may flow through distal end 12 and/or proximal end 16 . In some embodiments, fluid within fluid pathway 20 may flow through proximal end 16 in response to opening of septum 21 disposed within proximal end 16 . In some embodiments, the septum 21 may open in response to engagement of the blood collection device to the proximal end 16 of the adapter 10 . In some embodiments, the diaphragm 21 may include any suitable diaphragm and may differ from the diaphragm 21 shown. In some embodiments, the diaphragm 21 may include an accordion-like diaphragm 21 that may open when compressed in the distal direction.

In some embodiments, the fluid path 20 may include a non-linear portion 22 . Blood cells may experience shear stress as they flow through the fluid pathway 20 . The maximum shear stress follows the wall or wall shear stress of blood cells. Wall shear stress on blood cells is considered a major cause of mechanical damage to blood cells. In some embodiments, the non-linear portion may promote increased flow resistance within the vascular access system to dissipate pressure differentials and reduce shear stress experienced by red blood cells.

In some embodiments, the non-linear portion 22 may form a coil shape, an S-shape, or other suitable shape. 1A-1B , in some embodiments, the non-linear portion 22 may comprise a coil shape, which may comprise a helical shape. In some embodiments, the fluid flowing through the non-linear portion cannot flow linearly. In some embodiments, the non-linear portion 22 may increase the length of the fluid path 20 through the adapter 10 , thereby increasing flow resistance and reducing blood flow within the adapter 10 . In these embodiments, the risk of hemolysis during blood collection may be reduced.

In some embodiments, the length of the fluid path 20 of the adapter 10 may be selected based on one or more of the following: the gauge and/or length of the catheter, the configuration of the catheter assembly configuration, or a clinical setting. In some embodiments, the fluid path 20 may include a length L. In some embodiments, length L may extend from a distal end of fluid path 20 to a proximal end of fluid path 20 . In one example, the length L may extend from the distal end 24 of the fluid path 20 to the proximal end 26 of the fluid path 20 . As another example, length L may extend from a distal end of tube 28 to a proximal end of tube 28 . In some embodiments, length L may correspond to one length or the entire length of adapter 10 . In some embodiments, the fluid pathway 20 may extend along the entire length of the adapter 10 from the most distal to the most proximal of the adapter 10 . In some embodiments, the fluid pathway 20 may include an inner diameter D. In some embodiments, the inner diameter D may be constant along the length L.

The fluid flow in the fluid path 20, which can be tubular, can be analyzed using the Poiseuille equation:

where ΔP is the change in pressure gradient over the length of the fluid path 20, D and L are the inner diameter and length of the fluid path 20, respectively, μ is the viscosity of the fluid,

는 유체 저항이다. μ는 유체의 점도이고 기하학적 연장부의 일부가 아니기 때문에, 거리 계수(Gf)는 Rf(유체 저항)가

로 되도록 규정되며, 이때

이다.

is the fluid resistance. Since μ is the viscosity of the fluid and is not part of the geometric extension, the distance factor (Gf) is

is stipulated to be, at this time

to be.

In some embodiments, fluid path 20 may have multiple portions having lengths L1 , L2 , L3 and inner diameters D1 , D2 , D3 , the distance factor being:

In some embodiments, the fluid path 20 may have an inner diameter that varies over the length of the fluid path 20, the distance factor being:

In some embodiments, the fluid pathway 20 may have a non-circular cross-section or may have a complex inner diameter profile. Next, the distance factor can be determined by measuring the flow rate (Q) at a given pressure (ΔP) for a fluid of known viscosity (μ):

The Gf value of the fluid path 20 is the maximum shear stress for each catheter gauge, previously considered the best standard for blood withdrawal, from the BD 21G VACUTAINER® UltraTouch™ Push Button Blood Collection Set (Becton, Franklin Lakes, NJ). (available from Dickinson & Co) to be reduced to equal to or less than the maximum shear stress. In some embodiments, Gf may be greater than or equal to 3.83E+06 (1/in ³ ) when an 18G catheter is used, which may reduce wall shear stress to reduce hemolysis. In some embodiments, Gf may be greater than or equal to 3.27E+06 (1/in ³ ) when a 20G catheter is used, which may reduce wall shear stress to reduce hemolysis. In some embodiments, Gf may be greater than or equal to 3.33E+06 (1/in ³ ) when a 22G catheter is used, which may reduce wall shear stress and thereby reduce hemolysis. In some embodiments, Gf may be greater than or equal to 1.50E+07 (1/in ³ ) when a 24G catheter is used, which may reduce wall shear stress and thereby reduce hemolysis. In some embodiments, Gf may include other values. In some embodiments, the Gf value of the fluid path may be selected to reduce the maximum shear stress for each catheter gauge equal to or less than the maximum shear stress of the BD 25G VACUTAINER® ^UltraTouch ™ push button draw set (Becton, Dickinson & Company of Franklin Lakes, New Jersey).

In some embodiments, when an 18G catheter is used, Gf may be equal to 3.83E+06(1/in ³ ) + or −10%, + or −25%, + or −50%, or + or −75%. It can reduce the shear stress of the wall, thereby reducing the hemolysis. In some embodiments, when a 20G catheter is used, Gf is 3.27E+06 (1/in ³ ) + or −10%, + or −25%, + or −50%, or + or −75%, which is hemolysis To reduce the action, the wall shear stress can be reduced. In some embodiments, when a 22G catheter is used, Gf may be 3.33E+06(1/in ³ ) + or −10%, + or −25%, + or −50%, or + or −75% and , which can reduce the wall shear stress to reduce hemolysis. In some embodiments, when a 24G catheter is used, Gf may be equal to 1.50E+07 (1/in ³ ) + or −10%, + or −25%, + or −50%, or + or −75%. It can reduce the wall shear stress, thereby reducing the hemolysis. In some embodiments, Gf may include other values that may be selected based on the gauge of the catheter. In some embodiments, the Gf value may be chosen to be the same for 22G-18G catheters.

In some embodiments, the non-linear portion 22 may facilitate the miniature adapter 10 while reducing the risk of hemolysis. In some embodiments, the non-linear portion 22 may extend through a tube 28 , a groove 56 (see, eg, FIGS. 6A-6C ) or other suitable structure. In some embodiments, the tube 28 . The distal end of the tube 28 and/or the proximal end of the tube 28 may be secured within the adapter 10 in a variety of suitable locations.

In some embodiments, adapter 10 may include a lumen 30 , which lumen 30 extends through distal end 12 of adapter 10 and proximal end 16 of adapter 10 . can be In some embodiments, tube 28 may be disposed within lumen 30 . In some embodiments, the adapter 10 may include an intermediate portion 32 disposed between the distal end 12 and the proximal end 16 . In some embodiments, the intermediate portion 32 may surround the tube 28 . In some embodiments, adapter 10 receives a tube 28 having only openings in adapter 10 at distal end 12 and proximal end 16 .

2A-2D , in some embodiments, the proximal end 16 may be coupled to a blood collection device 34 . For example, the proximal end 16 may be integrated with the blood collection device 34 or formed in a monolithic manner with the blood collection device 34 as a single unit. As another example, the proximal end 16 may include a female luer connector that may be coupled with a male luer connector of the blood collection device 34 .

As shown in FIG. 2A , in some embodiments, the blood collection device 34 may include a needle assembly 36 , the needle assembly 36 including a needle 38 configured to receive a blood collection container. can do. In these and other embodiments, the blood collection vessel may include a vacuum blood collection tube. In some embodiments, all or part of the air is removed from the blood collection container such that the pressure within the blood collection container is lower than ambient pressure.

In some embodiments, the needle assembly 36 may include one or more threads that may be configured to couple to a holder 40 , which may be generally cylindrical and configured to support a blood collection vessel. can In some embodiments, the holder 40 may be integrally formed with the needle assembly 36 or coupled to the needle assembly 36 through bonding or other suitable method. In some embodiments, the holder 40 may surround the needle 38 . In some embodiments, needle assembly 36 and holder 40 are, for example, ^VACUTAINER® LUER-LOK available from Becton Dickinson and Company of Franklin Lakes, New Jersey, for example. may include or correspond to a luer lock access device such as a ™ Access Device. In some embodiments, the distal end of the needle assembly 36 may include a male luer connector compatible with the proximal connector 18 .

In some embodiments, the proximal end of the needle 38 may be enclosed within an elastomeric sheath 42 . In some embodiments, the elastomeric sheath 42 may include an open distal end and a closed proximal end. In some embodiments, as the blood collection vessel 34 pushes the elastomeric sheath 26 distally, the needle 38 may puncture the elastomeric sheath 42 and the needle 38 is inserted into the cavity of the blood collection vessel. can be

In some embodiments, the fluid path of a vascular access system, which may include one or more of a needle assembly 36 , an adapter 10 , and a catheter assembly 37 (which may include an extension tube), is configured such that, upon drawing, blood It may include the entire flow of blood collection pathways. The system distance coefficient Gfs for the fluid path of the vascular access system can be determined in a similar manner as previously described.

In some embodiments, the system distance factor Gfs may be greater than or equal to 7.34E+06 (1/in ³ ). In some embodiments, Gfs may include other values. In some embodiments, the system distance factor Gfs may be 7.34E+06(1/in ³ ) + or −10 percent, + or −25 percent, + or −50 percent, or + or −75 percent. In some embodiments, Gfs may include other values that may be selected based on the gauge and/or length of the catheter. In some embodiments, the inner diameter of adapter 10 may be greater than or equal to the minimum inner diameter of the remainder of the entire blood collection path for blood collection.

As shown in FIG. 2C , in some embodiments, the blood collection device 34 may include a syringe 35 that may include a pressurized plunger.

2D , in some embodiments, the blood collection device 34 may include a needle assembly 36 , which may not include a holder 40 .

3A-3B, an adapter 44 is shown in accordance with some embodiments. In some embodiments, adapter 44 may be similar or identical to adapter 10 of FIGS. 1A-2D in terms of features and/or operations including one or more. In some embodiments, the distal connector 14 of the adapter 10 includes a blunt cannula 46 that may be inserted into a portion of the catheter assembly and/or one or more arms 48 that may be secured to a portion of the catheter assembly. may include

4A-4B, an adapter 48 is shown in accordance with some embodiments. In some embodiments, adapter 48 may be similar or identical to adapter 10 of FIGS. 1A-2D and/or adapter 44 of FIGS. 3A-3B in terms of one or more included features and/or operations. have. In some embodiments, the distal connector 14 of the adapter 10 may include a male luer slip connector 50 .

5, an adapter 52 is shown in accordance with some embodiments. In some embodiments, adapter 52 may be similar or identical to one or more of the following in terms of one or more included features and/or operations: adapter 10 of FIGS. 1A-2D , 3A-3B . adapter 44, and adapter 48 of FIGS. 4A-4B. In some embodiments, the non-linear portion 22 may form an S-shape 54 or other suitable shape.

6A-6C, an adapter 55 is shown in accordance with some embodiments. In some embodiments, adapter 55 may be similar or identical to one or more of the following in terms of one or more included features and/or operations: adapter 10 of FIGS. 1A-2D , 3A-3B . adapter 44 , adapter 48 in FIGS. 4A-4B , and adapter 52 in FIG. 5 . For example, the adapter 55 may be coupled to a blood collection device 34 (see, eg, FIGS. 2A-2D ).

In some embodiments, the non-linear portion 22 of the fluid pathway 20 may include a channel or groove 56 . In some embodiments, the groove 56 may be disposed on the outer surface of the inner component 58 , and the inner component 58 may be coupled to the outer component 60 .

In some embodiments, the grooves 56 may include a coil or spiral shape. In some embodiments, the groove 56 may be proximal to the inner surface of the outer component 60 , wherein the outer component 60 allows fluid flowing through the groove 56 to flow through the proximal and distal ends of the groove 56 . The groove 56 may be closed so that the groove 56 does not escape except at the end.

In some embodiments, contact between inner component 58 and outer component 60 may form a seal between inner component 58 and outer component 60 . In some embodiments, the outer surface of inner component 58 may include a sealing element 61 , which may include silicone, rubber, plastic, or other suitable material. In some embodiments, the sealing element 61 may comprise a coil or helical shape and may be offset from the groove 56 in the distal-proximal direction. In some embodiments, sealing element 61 may prevent fluid from exiting groove 56 except at the distal and proximal ends of groove 56 .

In some embodiments, the outer diameter of the inner component 58 may be approximately equal to or slightly smaller than the inner diameter of the outer component 60 so that the inner component 58 fits within the outer component 60 . In some embodiments, the inner surface of the outer component 60 may be generally cylindrical and the outer surface of the inner component 58 may be generally cylindrical. In some embodiments, inner component 58 and outer component 60 may be concentric. In some embodiments, inner component 58 and outer component 60 may be integrally formed or formed in a monolithic manner as a single unit.

In some embodiments, outer component 60 may include a distal end 12 that may include the distal connector 14 of FIGS. 1 , 3 or 4 or other suitable connector. In some embodiments, inner component 58 may include a proximal end 16, which may include a proximal connector 18, such as a female luer connector or other suitable connector. .

In some embodiments, the proximal end of the groove 56 can include an aperture 62 that can fluidly connect the groove 56 to the opening 63 of the proximal end 16 . Similarly, in some embodiments, the distal end of the groove 56 may include an aperture that may fluidly connect the groove 56 to the opening 64 of the distal end 12 .

All examples and conditional language recited herein are for educational purposes to aid in understanding the present disclosure and concepts by the inventor to advance the art, and are not intended to be limited to the specifically recited examples and conditions. should be interpreted Although embodiments of the present invention have been described in detail, it should be understood that various changes, substitutions, and modifications may be made without departing from the spirit and scope of the present invention.

Claims (20)

a distal end comprising a distal connector configured to couple to the catheter assembly;
a proximal end comprising a proximal connector configured to couple to a blood collection device; and
An adapter disposed between the distal end and the proximal end and comprising a fluid path comprising a non-linear portion. The adapter of claim 1 , wherein the non-linear portion forms a coil shape. The adapter of claim 1 , wherein the non-linear portion forms an S-shape. The adapter of claim 1 , wherein the terminal connector comprises a male luer threaded connector. The adapter of claim 1 , wherein the end connector comprises a male luer slip connector. The adapter of claim 1 , wherein the distal connector comprises a blunt cannula. The adapter of claim 1 , wherein the proximal connector comprises a female luer connector. The adapter of claim 1 , wherein the non-linear portion extends through the tube. 9. The adapter of claim 8, further comprising a lumen extending through the distal end and the proximal end, wherein the tube is disposed within the lumen. 10. The adapter of claim 9, wherein the adapter further comprises a middle portion disposed between the distal end and the proximal end, the intermediate portion surrounding the tube. blood collection device; and
A blood collection set comprising an adapter, comprising:
The adapter is:
a distal end comprising a distal connector configured to couple to the catheter assembly;
a proximal end coupled to the blood collection device; and
A blood collection set disposed between the distal end and the proximal end and comprising a fluid path comprising a non-linear portion. The adapter of claim 1 , wherein the blood collection device comprises a syringe. The adapter of claim 1 , wherein the blood collection device comprises a needle configured to puncture the seal of an empty blood collection tube. 14. The adapter of claim 13, wherein the blood collection device further comprises a cylindrical holder extending about the needle. The adapter of claim 1 , wherein the non-linear portion forms a coil shape. The adapter of claim 1 , wherein the non-linear portion forms an S-shape. The adapter of claim 1 , wherein the distal connector comprises a male luer threaded connector. The adapter of claim 1 , wherein the terminal connector comprises a male luer slip connector. The adapter of claim 1 , wherein the distal connector comprises a blunt cannula. The adapter of claim 1 , wherein the proximal end comprises a proximal connector and the proximal connector comprises a female luer connector.

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